- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07559318
Post-Emergency Optimization of Antibiotic Therapy for Urinary Tract Infection (UTI) (REVIU48)
Post-Emergency Optimization of UTI Antibiotic Therapy: "Fluoroquinolones and Third-Generation Cephalosporins Under the Spotlight"
Prospective, multicenter, non-interventional study conducted over 6 months, including patients presenting to the emergency department with suspected urinary tract infection managed as outpatients and discharged with or without empiric antibiotic therapy.
Discharge antibiotic prescriptions are reviewed, with subsequent reassessment and optimization of treatment based on urine culture and susceptibility results
Study Overview
Status
Intervention / Treatment
Detailed Description
Urinary tract infections are a frequent cause of emergency department visits, accounting for substantial antibiotic use. Data from the OSCOUR (Organisation de la Surveillance Coordonnée des Urgences) network estimate around 5,000 weekly visits. Resistance rates among Enterobacteriaceae in urine samples are particularly high, largely driven by the widespread use of broad-spectrum antibiotics, especially fluoroquinolones, which are commonly prescribed as empiric therapy. Given their potential for serious adverse effects and their strong selective pressure for resistance, stricter control of their use is warranted, yet remains insufficient.
In current emergency practice, conditions such as pyelonephritis or male urinary tract infections are often treated with broad-spectrum antibiotics that are continued even when pathogens are susceptible to narrower agents. De-escalation to narrower-spectrum therapies would help preserve the microbiota and limit resistance.
This study is a prospective, multicenter, non-interventional observational study conducted over 6 months. It includes patients presenting to the emergency department with suspected urinary tract infections managed on an outpatient basis and discharged with or without empiric antibiotic therapy. Antibiotic treatments are reassessed 48 - 72 hours after inclusion by a physician, allowing for patient follow-up and potential modification of the initial prescription based on urine culture and susceptibility results, in accordance with current guidelines.
The study aims to assess the value of this reassessment strategy in improving antimicrobial stewardship for urinary tract infections in emergency settings and to inform future optimization of clinical practices.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anna BELKACEM, MD
- Phone Number: 01 43 86 21 62
- Email: anna.belkacem@chiv.fr
Study Contact Backup
- Name: Wissem TOUADI, Resident
- Email: wissemtouadi@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or over
- Patients presenting at emergency department, with symptoms suggestive of a urinary tract infection suitable for outpatient management (uncomplicated cystitis or cystitis at risk of complications, uncomplicated pyelonephritis or pyelonephritis at risk of complications, male urinary tract infection with or without fever) who have had a urine culture taken
Exclusion Criteria:
- Refusal to participate in the study
- Vulnerable person (person under guardianship or trusteeship, minor, person deprived of liberty, person unable to express their refusal)
- Pregnant women
- Severe urinary tract infection (sepsis, septic shock or requiring drainage, except for low urinary catheterisation)
- Hospitalisation for a urinary tract infection or decompensation of another comorbidity
- Suspected urinary tract infection without a urine culture having been performed
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Suspected of outpatient urinary tract infection
Inclusion of patients with outpatient urinary tract infection in emergency department
|
Re assessment of antibiotic therapy at 48 hours based on urine culture results : discontinuation or de-escalation to a narrower-spectrum agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assess changes in fluoroquinolone and third-generation cephalosporin prescribing in outpatient urinary tract infections following adjustment based on urine culture and susceptibility results.
Time Frame: At 48 hours - 72 hours after the patient inclusion
|
At 48 hours - 72 hours after the patient inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence (percentage) of adverse effects associated with antibiotics.
Time Frame: At 1 month after the consultation in the Emergency department
|
At 1 month after the consultation in the Emergency department
|
|
Incidence (percentage) of antibiotic prescription savings in the Emergency department for outpatient urinary tract infections (cessation of prescription, shortening of treatment duration and/or narrowing of the spectrum) following the intervention
Time Frame: At 48 hours - 72 hours after the patient inclusion
|
At 48 hours - 72 hours after the patient inclusion
|
|
Assessment of patient satisfaction with medical follow-up via a question asked directly to the patient via a questionnaire (Better if more than 50 percent of patients are satisfied)
Time Frame: At 1 month after the consultation in the Emergency department
|
At 1 month after the consultation in the Emergency department
|
|
Assessment of patients' knowledge of antibiotic resistance via a question asked directly to the patient via a questionnaire (Better if more than 50 percent of patients are satisfied)
Time Frame: At 1 month after the consultation in the Emergency department
|
At 1 month after the consultation in the Emergency department
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Disease Attributes
- Infections
- Communicable Diseases
- Pathological Conditions, Signs and Symptoms
- Urinary Tract Infections
- Communicable Diseases, Emerging
Other Study ID Numbers
- REVIU48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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